Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy, safety and tolerability of different doses of azd0780 in patients with dyslipidemia

Conditions: Dyslipidemia

Summary: the primary purpose of this study is to measure the effect of different daily doses of azd0780 on low-density lipoprotein (ldl-c) levels compared with placebo in participants with dyslipidemia. the effect of azd0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. the concentration of azd0780 in blood at specific timepoints is measured, and the safety and tolerability of azd0780 will be evaluated. there is a follow-up after end of treatment, but expanded access is not available. the primary hypothesis is that at least one of the investigated doses of azd0780 is superior to placebo in lowering ldl-c level, in percent change from baseline up to week 12.


Eligibility criteria:
inclusion criteria: * males, and females of non-childbearing potential 18 to 75 years of age, inclusive, at the time of signing the informed consent. * participants with a fasting low-density lipoprotein cholesterol (ldl-c) higher than or equal to 70 mg/dl (1.8 mmol/l) and lower than 190 mg/dl (4.9 mmol/l) at screening. * participants with fasting triglycerides lower than 400 mg/dl (lower than 4.52 mmol/l) at screening. * should be receiving moderate or high-intensity statin therapy for more than or equal to 2 months prior to screening. * there should be no planned medication or dose change during study participation. * body mass index at or above 19.0 kg/m\^2. exclusion criteria: * history or presence of gastrointestinal, hepatic or renal disease or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs. * any uncontrolled or serious disease, or any medical (e.g., known major active infection or major hematological, renal, metabolic, gastrointestinal, respiratory, or endocrine dysfunction) or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk. * poorly controlled type 2 diabetes mellitus, defined as hemoglobin a1c (hba1c) greater than 10 percent at screening. * acute ischemic cardiovascular event in the last 12 months. * heart failure with new york heart association (nyha) class iii-iv. * malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or stage 1 prostate carcinoma) within the last 10 years. * recipient of any major organ transplant, e.g., lung, liver, heart, bone marrow, renal. * ldl or plasma apheresis within 12 months prior to randomization. * uncontrolled hypertension. * any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ecg) and any clinically important abnormalities in the 12 lead ecg as judged by the investigator.

Keywords: dyslipidemia, low-density lipoprotein cholesterol
supplementation with vitamin d improves leptin resistance

Conditions: Overweight; Obesity

Summary: participants will be randomly assigned in one of two groups. group a: oral supplementation with 4,000 iu of vitamin d (cholecalciferol). group b: oral supplementation with 400 iu of vitamin d (cholecalciferol). both treatments will be consumed daily for 6 months. outcomes will be evaluated at baseline, three and six months. variables related to leptin resistance will be evaluated. the main hypothesis is that vitamin d will diminish leptin resistance in overweight and obese women. if the hypothesis is confirmed, women will show a reduction in the resting energy expenditure: serum leptin ratio (ree: leptin ratio), as well as a reduction of hunger, body weight, body and abdominal fat and an increase in resting energy expenditure.

study subjects will get dietary advice and physical activity counseling. at the end of the study, participants with suboptimal vitamin d levels (\<80 nmol/l 25-oh-d) will receive treatment to normalize their vitamin d status. variables related to leptin resistance like resting metabolic expenditure, hunger, body weight and human body fat will be assessed. outcomes will include, glucose, insulin, c-reactive protein, inflammatory interleukins (il-6 \& tnf-α) and non-inflammatory interleukins (il-10 \& tgf-β-1).

Eligibility criteria:
inclusion criteria: * bmi: 25-29.9 * serum vitamin d levels: 20-80 nmol/l (25-oh-d) exclusion criteria: * liver disease * kidney disease * diabetes mellitus * malignity * any kind of hormonal disorder * medication that modify hunger/satiety answer and those medications that alter -the glucose/insulin metabolism * subjects with diet treatment to lose weight
hand grip strength as a marker of frailty in surgical patients

Conditions: Frailty

Summary: this study aims to assess if grip strength can be used as a single, objective surrogate of frailty assessment in the surgical population.

frailty is associated with worse outcomes. current screening surveys are cumbersome, most containing multiple components. for frail patients particularly, it can be difficult to ascertain all the information requested. there is a need for a simple, one step, objective screening measure of frailty. there is some evidence in the medicine patients that grip strength may be related to frailty, but no such information is available for surgical patients.

Eligibility criteria:
inclusion criteria: * general surgery patient admitted to the section of general surgery, trauma, and surgical critical care * age \>60 exclusion criteria: * pregnancy * untreated or metastatic malignancy * prisoners

Keywords: surgical outcomes
longitudinal analysis of right ventricular remodeling in response to prolonged strength training using 3d-echocardiography

Conditions: Cardiac Remodeling, Ventricular; Right Ventricular Hypertrophy

Summary: right ventricular (rv) physiological remodeling in response to prolonged strength exercise remains poorly studied. this prospective, non-randomized, single-center study, proposes to follow 24 healthy sedentary volunteers who will benefit from a high-intensity pure resistance training program over a 6-month period. the volunteers, aged between 18 and 40 years old and male, will be recruited and evaluated at the university hospital center of caen normandy. cardiac remodeling in response to physical exercise will be analyzed by trans-thoracic echocardiography repeated during the follow-up. the physical impact of the training program will be assessed by a treadmill exercise test predicting maximal oxygen consumption (vo2max) before and after completing the training, and an isokinetic muscular test repeated every 3 months. participants rest/activity cycles will be monitor before and after 3 months of training. the aim of the study is to demonstrate the existence of a physiologic rv remodeling in response to pure high-load resistance chronic exercise. the results will help to improve the understanding of the physiological rv response expected in strength athletes.


Eligibility criteria:
inclusion criteria: * age between 18 and 40 years * male gender * agree to participate in the study (signature of consent). * affiliated to an insurance scheme or beneficiary exclusion criteria: * female gender * inability to express consent * moderate physical activity over than 150 minutes or intensive physical activity over than 75 minutes per week on a regular basis for more than 6 consecutive months, according to the world health organisation criteria. * participation in competitive sports of ≥ ii and / or b according to mitchell's classification in the last 3 years. * ischemic and non-ischemic heart diseases * family history of unexplained sudden death * personal or family history of elastic tissue disease (marfan syndrome and related) * chronic diseases incompatible with physical exercise at high intensity * personal history of chemotherapy and / or radiotherapy * ≥ 1 cardiovascular risk factors * use of doping substances * body mass index \> 30 kg/m² * inclusion in another biomedical research protocol (during the present study or within 6 months before inclusion).

Keywords: right ventricle cardiac physiology strength training echocardiography
an observational study to evaluate efficacy, safety and clinical outcomes of currently used pharmaceutical therapies for controlled ovarian stimulation in assisted reproductive techniques

Conditions: Infertility

Summary: human gonadotrophins have been successfully used for the treatment of infertility for more than 30 years. this observational study is being conducted to evaluate the efficacy and safety of the gonadotropins used for controlled ovarian stimulation (cos) in assisted reproductive technologies (art).

the objective of this observational program is to evaluate the efficacy and safety of the gonadotropins used for cos in art. the clinical use of the various progesterone preparations will also be monitored and registered. all medications will be used according to normal clinical practice, as described in the summary of product characteristics (smpc). from the start of the program cycles data will be collected prospectively for 12 months and also a substantial amount of cycles will be analyzed retrospectively for the previous 6 months. data will be collected from all subjects stimulated by follicle stimulating hormone (fsh), with or without down regulation and exogenous lutenizing hormone (lh) supplementation, and final follicular maturation triggered by human chorionic gonadotropin (hcg) and luteal phase support by any means for cos in art and intracytosolic sperm injection (icsi). all the medications should be used according to usual clinical practice. data related to pretreatment (basal examination, history of infertility, lh suppression), stimulation (gonadotropin use, concomitant medications, luteal phase supplementation, ovulation triggering, cycle cancellation, fertilization methods), safety aspects and clinical outcome will be captured.

Eligibility criteria:
inclusion criteria: * this is a registry wherein data will be collected from all subjects stimulated by fsh, with- or without down regulation and exogenous luteinising hormone (lh) supplementation, and final follicular maturation triggered by hcg and luteal phase support by any means for controlled ovarian stimulation (cos) in assisted reproductive technique (art) and intracytoplasmic sperm injection (icsi).

Keywords: infertility controlled ovarian stimulation reproductive techniques, assisted sperm injections, intracytoplasmic gonal-f ovitrelle
clinical and electrophysiological evaluation of the effectiveness for manual lymphatic drainage

Conditions: Carpal Tunnel Syndrome; Electrophysical Evaluation; Manual Lymphatic Drainage

Summary: when the other usage areas of the manual lymphatic drainage technique in the literature, except for the treatment of lymphedema, were examined recently, it was seen that it was also applied in orthopedic and neurological cases in a limited number of studies. the aim of our study is to investigate the effectiveness of manual lymphatic drainage on clinical and electrophysiological findings in carpal tunnel syndrome


Eligibility criteria:
inclusion criteria: * diagnosis of mild to moderate carpal tunnel syndrome on electrodiagnostic examination * being between 20-55 years old * volunteering to participate in the treatment to be given exclusion criteria: * have a systemic inflammatory disease * having any disease that may cause polyneuropathy, such as diabetes mellitus * cognitive impairment * receiving psychotherapy * having a pacemaker * illiterate * having a disease affecting the central nervous system * having a hearing problem * any skin disease that would contraindicate manual lymphatic drainage * arterial or venous circulation disorder that would contraindicate manual lymphatic drainage
characterization of the phenotypic markers of b cell lymphocytes in rheumatoid arthritis

Conditions: Autoimmune Diseases

Summary: rheumatoid arthritis (ra): ra is a chronic inflammatory autoimmune disease that primarily affects the small joints, eventually leading to bone erosion and an inability to move (1). several immune cells participate in the pathogenesis of ra. one of those cells is b cell.

b cell population: b lymphocytes play several critical roles in the pathogenesis of rheumatoid arthritis. they are the source of the rheumatoid factors (rf) and anti-cyclic-citrullinated peptide (anti-ccp), which contribute to immune complex formation and complement activation in the joints (2). there is different b cell subpopulation according to the stage of maturation and activity. distinction of this subpopulation can be done by detection of different cd molecules expressed on cell surface (3). from all sub-population this research will focus on these immunophenotypes; immature, mature, memory and b-reg cells by using cd 19, cd24, cd38 \& cd27 respectively. joa˜ o e. fonseca and his team found the reduction in b cell subpopulation especially (pre- switched memory b cells) both in ra and arthritis in the early stage. this observation not related to using methotrexate or corticosteroid in the treatment. they used the classification of b cells with cd 19 mainly and then igd and cd27 to identify b cells (4). gabriella sármay team found that the number of b-reg cd19+ cd27+ il-10+ cells in peripheral blood is fewer in ra patients compared with healthy controls (5). interleukin 10: interleukin (il)-10 functions as an anti-inflammatory cytokine in rheumatoid arthritis. il-10 mrna levels were significantly elevated in synovial fluid mononuclear cells (sfmcs) from patients with ra compared with pbmcs peripheral blood mononuclear cells (pbmcs) from ra patients or healthy volunteers according to isomäki p (6). il 10 is primarily produced by monocytes mainly and, then by lymphocytes; type 2 t helper cells (th2), mast cells, cd4+cd25+foxp3+ regulatory t cells, and in a certain subset of activated t cells and b cells (7).

Eligibility criteria:
inclusion criteria: * patient diagnosed as rheumatoid arthritis that fulfilled acr/eular criteria (american college of rheumatology/european league against rheumatism). * (8) age \>18 years. b. exclusion criteria: * diagnosed patients with other autoimmune disease or other infections. * pregnant patients.

Keywords: rheumatoid arthritis ra - b cells (b lymphocyte).
cerebral near infrared spectroscopy during blood sampling from a peripheral artery catheter in preterm infants

Conditions: Cerebral Oxygenation; Cerebral Blood Flow; Prematurity

Summary: preterm infants often need peripheral artery catheters for invasive blood pressure recording and to facilitate blood sampling. near infrared spectroscopy is a method to evaluate cerebral oxygenation and as well as cerebral blood flow. sampling procedures with identical sampling volumes are performed at a short (40 seconds) and a long (70 seconds) time intervall while changes of cerebral oxygenation are measured. the investigators hypothesise that slower sampling decrease changes in cerebral blood flow.


Eligibility criteria:
inclusion criteria: * preterm infant (gestational age \<37+0) * peripheral arterial catheter (ulnary or radial artery) exclusion criteria: * complex organ malformation
diabetic foot ulcer prevention system (dfups) - part 2

Conditions: Diabetic Foot

Summary: the purpose of this study is to investigate whether regular measurement of skin foot temperature with a novel device (dfups) will prevent ulcer recurrence in diabetic patients at high risk of foot ulceration. it is planned to regularly measure the temperature of the feet of people with diabetes who have already had a foot ulcer which has subsequently healed. these measurements should allow the identification of hotspots on the foot and may be helpful when advising about ulcer risk and providing preventative treatment. it is hoped to find out whether the regular use of thermal images taken with the dfups device together with standard foot treatment may reduce the number of people with diabetes developing ulcers or even prevent foot ulcers.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * has either type 1 or type 2 diabetes * has intact feet as defined by the absence of a skin breakdown below the malleoli. * has neuropathy confirmed by impaired sensation to neurothesiometer (vibration perception threshold \> 25 volts on one or both feet) * has a past history of ≥1 foot ulceration (s) which has (have) resolved in the last 3 months * has palpable foot pulses on both feet (palpable posterior tibial artery pulse or dorsalis pedis artery pulse or both) * has no history of peripheral arterial disease * has footwear which in the opinion of the investigator is not likely to cause pressure damage * must be able to provide meaningful written informed consent for the study exclusion criteria: * is aged \<18 * has foot deformity that in the opinion of the investigator would interfere with the interpreting of the results of the study. * has previous history of foot surgery which in the opinion of the study investigator could interfere with the interpreting the results of the study * has active foot ulceration and infection * has active charcot osteoarthropathy * has established charcot foot deformity that in the opinion of the study investigator would interfere with the interpreting of the results of the study. * has any uncontrolled illness that, in the opinion of the study investigator, would interfere with interpreting the results of the study * has an implantable electronic device

Keywords: diabetic foot foot temperature diabetic foot ulcer
neurostimulation to treat refractory angina pectoris pain

Conditions: Angina Pectoris

Summary: the therapy under investigation involves an implanted medtronic neurostimulation system to relieve symptoms of angina pectoris pain. electrical impulses are applied to targeted areas of the spinal cord through an implanted lead (a flexible insulated wire) that is powered by an implanted battery.


Eligibility criteria:
inclusion criteria: * stable angina pectoris associated with reversible myocardial ischemia and significant coronary artery disease (cad) * classified as canadian cardiovascular society (ccs) angina class iii or iv * refractory angina despite receiving optimal/maximal medical treatment * not a candidate for bypass surgery, angioplasty or stent exclusion criteria: * not able to perform exercise treadmill testing * previously received therapeutic transcutaneous electrical nerve stimulation (tens) (within 2 years) or any spinal cord stimulation (scs) * has an implanted pacemaker/defibrillator (icd)

Keywords: angina pectoris pain
effectiveness of repeated motivational intervention to reduce ethanol intake during pregnancy

Conditions: Alcohol Abuse in Pregnancy

Summary: ethanol exposure during pregnancy is associated with adverse perinatal outcomes resulting in high healthcare costs. primary care centers whose attends low risk women will be randomized to apply a motivational intervention program to the mothers.

this is a cluster randomized simple masking controlled trial evaluating the effectiveness of repeated motivational interview (mi) during pregnancy on prevalence of ethanol intake together with offspring´s neurodevelopment. .

Eligibility criteria:
inclusion criteria: * maternal age at recruitment \> 18 years * speak spanish fluenty * women controlling their pregnancy in baix llobregat center and hospital sant joan de déu, who will attend their delivery in hospital sant joan de déu and parc sanitari sant joan de déu * viable singleton non- malformed fetus * first trimestre of gestation exclusion criteria: * multiple gestations * perinatal infections * fetal anomalies including chromosomal anormalities or structural malformations detected by ultrasound * premature rupture of membranes * uncontrolled or/and severe maternal chronic disease * language barriers * imposibility to obtain the sample (hair lenght below nine centimeters) * discolored hair * refusal to join the study

Keywords: motivational interview pregnancy ethanol intake
evaluation of preferences of consumers and clinicians for the management of shave biopsy sites with a polymem formulation dressing or current standard of care.

Conditions: Healing

Summary: shave biopsies are often uncomfortable during the healing process. this is a preliminary study to determine if patients and clinicians prefer using polymem formulating dressings on shave biopsy sites compared to the current standard of practice, which is antibiotic ointment covered with a band-aid type dressing.

only individuals who require 2 shave biopsies on the same treatment day will be entered in the study. each participant serves as their own control.

Eligibility criteria:
inclusion criteria: * individuals that are going to have two shave biopsies performed on the same day will be evaluated for inclusion in the study. exclusion criteria: * those that have used systemic corticosteroids in the last three months. * those with any medical condition leading to immunosuppression * those with a history of keloid formation * those with documented compromised wound healing potential * history of psoriasis or eczema in the last 2 years * those with an active infection * those that use aspirin or non-steroidal anti-inflammatory drugs more than 3 times per week for pain (daily low dose aspirin use for cardiovascular health is not an exclusion criteria) * those that have inflammatory conditions such as rheumatoid arthritis or crohn's disease * those that have clinical signs of malnutrition that could interfere with wound healing * those that have a history of allergies to any wound dressing or medical tape * those that are not able to change the dressing themselves and do not have anyone in their household that can change the dressings if needed. * those younger than 18 years old

Keywords: shave biopsy management "biopsy/adverse effects"[mesh] "biopsy/complications"[mesh])